OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
FDA 510(k) clearance K990509 · decided 1999-05-18
Clearance details
- K-number
- K990509
- Device name
- OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
- Applicant
- Implemed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-18
- Decision date
- 1999-05-18
- Days to decision
- 89 days
- Clearance type
- Abbreviated
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.